Explanation of Changes

Explanation for Program Changes or Adjustments

This is a request for a revision. There are 13 total forms being changed as a part of this revision and no new forms being added. Most of the collection activities remain the same, however, there are a few proposed revisions including minor revised language and rewording to improve clarity and readability of the data collection forms.

In response to the Notice of Decision published in the Federal Register on March 29, 2024 regarding the update of the Statistical Policy Directive No. 15:  Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity (SPD 15), the  EIP programs (ABCs, FoodNet, FluSurv-NET, and HAIC) under OMB 0920-0978 will comply with the updated standards set for Federal data on Race and Ethnicity by and/or before the March 2029 deadline.

Due to the timing of the Influenza data collection season (October 1), FluSurv-NET has incorporated the updated race and ethnicity (R/E) data standards in their data collection forms as part of this Revision to capture the updated R/E variable at the beginning of their data collection season. The remaining 3 EIP programs (ABCs, FoodNET, and HAIC) will update the R/E variable in a subsequent non-substantive change request to maintain data integrity since their respective data collection period begins on Jan 1. Maintaining data integrity and consistency is paramount to quality data analysis therefore, waiting to incorporate the race and ethnicity changes at the beginning of FY25 for ABCs, FoodNET and HAIC would ensure that the race ethnicity data variable will possess consistent parameters and easier for analysis at the beginning of their data collection cycle as opposed to mid-season.

In this revision, EIP, specifically FluSurv-Net, is requesting an exemption to the requirement to collect more detailed data beyond the minimum categories. The justification for using the minimum race and ethnicity categories are as follows: 1) Detailed data collection would potentially be more burdensome for the state surveillance officers and may not add as much value, given that the additional check boxes will likely have few case counts; 2) There will not likely be sufficient number of cases identified to allow the disaggregated racial/ethnic categories to be analyzed separately; any analysis done will require aggregating the data into the minimum required categories; 3) EIP data collection is primarily conducted through medical record reviews and not through patient interviews. The expanded data collection would be intended for interviews rather than chart reviews, therefore not applicable to EIP data collection; 4) The detailed race/ethnicity population groups likely comprise a small percentage of the EIP surveillance catchment areas and the collection of these groups could pose additional risk to data privacy and identification of individuals.

Details of each collection instrument for the revision are as follows:

ABCs:

This Revision includes proposed changes to 3 of the 5 approved Active Bacterial Core surveillance (ABCs) forms and no new ABCs data collection tools (form/s) detailed below: 

Approved Forms with no changes noted:

1) ABC.100.3  ABCs H. influenzae Neonatal Sepsis Expanded Surveillance Form  

2) ABC.100.4  ABCs Severe GAS Infection Supplemental Form 

Changes to Approved Forms: 

1) ABC.100.1 ABCs Case Report Form

2) ABC.100.2 ABCs Invasive Pneumococcal Disease in Children and Adults Case Report Form

3) ABC.100.5 ABCs Neonatal Infection Expanded Tracking Form

 

ABCs Case Report Form (ABC.100.1)
Type of Change	Itemized Changes / Justification	Impact to Burden
Deletion	Removal of “other prior illness” and “specify other prior illness” fields from Q27 Underlying causes or prior illnesses section.  Justification: Other prior illness has been kept on the form for site use only. Removal of this option from the form will reduce confusion on when to select “No underlying conditions” for sites and improve data edit checks.	No change to burden
ABCs Invasive Pneumococcal Disease in Children and Adults Case Report Form (ABC.100.2)
Type of Change	Itemized Change / Justification	Impact to Burden
Addition	Most recent influenza vaccine date  Justification: Information on these vaccines will help to better assess pneumococcal disease risk and vaccine effectiveness.	No change to burden.   Surveillance staff already review patient’s medical chart as well as State immunization information systems (IIS) or vaccine registries, when possible, to check for existing pneumococcal vaccination information questions. If influenza vaccination information is available in the same source(s) influenza vaccination date will also be recorded.
Addition	Most recent COVID-19 vaccine date  Justification: Information on these vaccines will help to better assess pneumococcal disease risk and vaccine effectiveness.	No change to burden  Surveillance staff already review patient’s medical chart as well as State immunization information systems (IIS) or vaccine registries, when possible, to check for existing pneumococcal vaccination information questions. If COVID-19 vaccination information is available in the same source(s) COVID-19 vaccination date will also be recorded.
Addition	RSV vaccine date (complete for adults ≥65 years only)  Justification: Information on these vaccines will help to better assess pneumococcal disease risk and vaccine effectiveness.	No change to burden  Surveillance staff already review patient’s medical chart as well as State immunization information systems (IIS) or vaccine registries, when possible, to check for existing pneumococcal vaccination information questions. If RSV vaccination information is available in the same source(s) RSV vaccination date will also be recorded. This information will only be checked for adults 65 years and older.
Addition	RSV monoclonal antibody date (complete for children <5 years only)  Justification: Information on these vaccines will help to better assess pneumococcal disease risk and vaccine effectiveness.	No change to burden  Surveillance staff already review patient’s medical chart as well as State immunization information systems (IIS) or vaccine registries, when possible, to check for existing pneumococcal vaccination information questions. If RSV preventive antibody information is available in the same source(s) RSV preventive antibody date will also be recorded. This information will only be checked for adults children under 5 years old.
ABCs Neonatal Infection Expanded Tracking Form (ABC.100.5)
Type of Change	Itemized Change / Justification	Impact to Burden
Deletion	Removal of “other prior illness” and “specify other prior illness” fields from Q14a Maternal underlying or prior illnesses section.   Justification: Other prior illness has been kept on the form for site use only. Removal of this option from the form will reduce confusion on when to select “No underlying conditions” for sites and improve data edit checks.	No change to burden

FoodNet:

This Revision includes proposed changes to 1 of the 3 approved FoodNet forms and no new FoodNet data collection tools (form/s) detailed below: 

Approved Forms with no changes noted:

1) FN.200.9 Hemolytic Uremic Syndrome (HUS) Surveillance

2) FN.200.10 FoodNet Clinical Laboratory Practices and Testing Volume

Changes to Approved Forms: 

1) FN.200.1 – FN.200.8 FoodNet Active Surveillance Data Elements List 

FoodNet Active Surveillance Data Elements List (FN.200.1)
Type of Change	Itemized Changes / Justification	Impact to Burden
Value set change for variable AgClinicTestType	The values of “Meridian Curian Shiga Toxin” and “Lab-developed test” were added for the variable AgClinicTestType to assist data collectors in capturing data in a standardized fashion to improve accuracy.	No impact to burden
Value set change for variable AgSPHLTestType	The value of “Meridian Curian Shiga Toxin” was added for the variable AgSPHLTestType assist data collectors in capturing data in a standardized fashion to improve accuracy.	No impact to burden

FluSurv-NET:

This Revision includes proposed changes to 4 of the approved FluSurv-NET forms and no new FluSurv-NET data collection tools (form/s) detailed below: 

Changes to Approved Forms: 

1) FSN.300.1 Influenza Hospitalization Surveillance Network (FluSurv-NET) Case Report Form

2) FSN.300.2 Influenza Hospitalization Surveillance Project Vaccination Phone Script and Consent Form (English/Spanish) 

3) FSN.300.3 Influenza Hospitalization Surveillance Project Provider Vaccination History Fax Form (Children/Adults) 

4) FSN.300.4 FluSurv-NET Laboratory Survey

Influenza Hospitalization Surveillance Network (FluSurv-NET) Case Report Form (FSN.300.1)
Type of change		Itemized changes/justification	Impact to burden
Revision		C. Enrollment Information 8. Race and/or Ethnicity (select all that apply) American Indian or Alaska Native Asian Black or African American Hispanic or Latino Middle Eastern or North African Multiracial, not otherwise specified Native Hawaiian or Pacific Islander White Unknown Justification Due to change in OMB standards, race and ethnicity questions were combined into a question and allowed for all that applied to be selected. A new category for “Middle Eastern or North African” was added. Although the OMB standards include a “Not specified” category, this was revised to be “Unknown” to be consistent with past approved case report forms and an “unknown” option is used for almost all other variables and is needed for data cleaning and analysis purposes. OMB standards do not include “Multiracial, not otherwise specified”, but this category will be kept for consistency with previous seasons and situations where medical charts do not specify additional details about multirace. This is not a change and does not impact burden Race/ethnicity will be collected through the minimum categories for the 2024-2025 season, rather than the expanded categories, with the following justification: Detailed data collection would potentially be more burdensome for the surveillance staff and may not add as much value, given that the additional check boxes will likely have few case counts There will not likely be sufficient number of cases identified to allow the disaggregated racial/ethnic categories to be analyzed separately; any analysis performed will probably require aggregating the data into the minimum required categories FluSurv-NET data collection is primarily conducted through medical record reviews and not through patient interviews. The detailed data collection seems to be more intended for interviews rather than chart reviews. The detailed race/ethnicity population groups likely comprise a small percentage of our surveillance catchment areas and the collection of these groups could pose additional risk to data privacy and identification of individuals	Minimal, <1 minute increase
Revision		C. Enrollment Information 14.Where did the patient reside at the time of hospitalization (Indicate type of residence)? Private residence Private residence with services Homeless/Shelter/Temporary housing Nursing home/Skilled nursing facility Substance abuse treatment Center Hospitalized at birth Rehabilitation facility Corrections facility Hospice Assisted living/Residential care LTACH Group/Retirement home Psychiatric/Behavioral Health Facility Other long term care facility Other, specify: ______ Unknown Justification Renaming “Psychiatric facility” to “Psychiatric/Behavioral Health Facility” to reflect more inclusive health facility types	No change to burden
Revision		D. Influenza Testing Results 1-3. Test Rapid Antigen Standard/Rapid Molecular Assay Viral Culture Fluorescent Antibody Method Unknown Justification Deleted Rapid Molecular Assay and combined with Standard Molecular Assay to alleviate the burden on sites distinguishing the difference between the two test types. Medical charts may not have additional details on the type of test used for lab confirmation Deleted Serology because it has not been identified as a mode of lab confirmation for flu hospitalizations in recent seasons	Minimal, <1 minute decrease
Addition		E. Other Interventions and ICU (For Questions 1-5, select the highest level of oxygen support received) 5. Supplemental Oxygen? Yes No Unknown Justification Changed the section header to only record the highest level of oxygen support needed only. It would be beneficial to know the highest level of oxygen a patient received during hospitalization as an indicator of disease severity Added Supplemental Oxygen question to better understand impact of severity of respiratory viral infection upon admission	Minimal, <1 minute increase
Revision		F. Outcome 2.If discharged alive, please indicate to where: Private residence Private residence with services Homeless/Shelter/Temporary housing Nursing home/Skilled nursing facility Substance abuse treatment Center Hospitalized at birth Rehabilitation facility Corrections facility Hospice Assisted living/Residential care LTACH Group/Retirement home Psychiatric/Behavioral Health Facility Other long term care facility Other, specify: ______ Unknown Justification Renaming “Psychiatric facility” to “Psychiatric/Behavioral Health Facility” to reflect more inclusive health facility types	No change to burden
Revision		G. Admission and Patient History 2. Acute signs/symptoms present at admission (began or worsened within 2 weeks prior to admission)(Select all that apply) Respiratory symptoms Chest congestion Congested/runny nose Cough Hemoptysis/bloody sputum Shortness of breath/respiratory distress/hypoxia Sore throat URI/ILI Wheezing Justification Added “hypoxia” symptom to the existing symptom of “shortness of breath/respiratory distress” to capture symptoms resulting from low levels of oxygen	No change to burden
Revision		G. Admission and Patient History 7. Smoker (tobacco) (for patients > 12 years): Current Former No/Unknown Justification Updated the age limit for smoker (tobacco) question to > 12 years to assess as a risk factor for severe disease among adolescents and adults	Minimal, <1 minute decrease
Revision		G. Admission and Patient History 9. Alcohol misuse (for patients > 12 years): Current Former No/Unknown Justification Change question from “Alcohol abuse” to “Alcohol misuse” to use less stigmatizing language Updated the age limit for alcohol question to > 12 years to assess as a risk factor for severe disease among adolescents and adults	Minimal, <1 minute decrease
Revision		G. Admission and Patient History 10. Substance misuse (for patients > 12 years): Current Former No/Unknown Justification Changed “Substance abuse” question to “Substance misuse” to use less stigmatizing language Updated the age limit for substance abuse question to > 12 years to assess as a risk factor for severe disease among adolescents and adults	Minimal, <1 minute decrease
Addition		G. Admission and Patient History 8. Environmental tobacco smoke exposure (for pediatric patients ≤12 years) Yes No Unknown Justification Added question to better capture this as a risk factor for respiratory disease among young children and young adolescents	Minimal, <1 minute increase
Revision		G. Admission and Patient History 11. Substance Misuse Type or Route (current use only) (select all that apply) Cocaine IVDU Opioids Polysubstance abuse – not otherwise specified Methamphetamines Marijuana Other, specify: _____ Unknown Justification Changed “Substance Abuse Type” to "Substance Misuse Type or Route (current use only)" in the question (no change to selections) to avoid using stigmatizing language	No change to burden
Revision		H. Underlying Medical Conditions 1f. Hypertension Moved “Hypertension” header category to right before “Cardiovascular Disease” section Justification Moved this condition closer to similar conditions for ease of collection for sites	No change to burden
Revision		H. Underlying Medical Conditions 1g. Congenital Heart Disease (Specify) Atrial septal defect (ASD) Patent Ductus Arteriosus (PDA) Pulmonic stenosis Tetralogy of Fallot Ventricular septal defect (VSD) Justification Added Patent Ductus Arteriosus (PDA) as a selectable congenital heart disease because it may be more commonly seen than other congenital heart disease options (including ASD and VSD)	Minimal, <1 minute increase
Revision		H. Underling Medical Conditions 1c. Diabetes Mellitus (DM) Moved “Diabetes Mellitus” as new header category for before Chronic Metabolic Disease Justification Moved condition so it is easier for surveillance staff to record condition	No change to burden
Revision		H. Underlying Medical Conditions 1q. Other: Bedbound Feeding tube dependent (PEG, see list) Trach dependent/Vent dependent Wheelchair dependent Other, specify: ______________ Justification Added new checkbox “Bedbound” under the “Other” header category as one way to assess frailty	Minimal, <1 minute increase
Deletion		Removed entire Bacterial Pathogens section Justification Data collected in previous seasons have demonstrated in part the challenges in determining positive results indicate contaminant or a pathogen-causing disease and the burden in collecting and interpreting these data elements. This section was removed from the case report form.	2-3 minute decrease in burden
Revision		I. Viral Pathogens 1b. Coronavirus SARS-CoV-2 Moved location of “Coronavirus SARS-CoV-2” towards the top to be closer to “RSV” Justification Moved location for ease of collection for sites	No change to burden
Revision		K. Chest X-ray 1. Was a chest x-ray taken during the first 3 days of admission (for patients ≤17 years)? Yes No Unknown Justification Revised past and previously OMB-approved question “Was a chest x-ray taken during the first 3 days of admission” to “Was a chest x-ray taken during the first 3 days of admission (for patients ≤17 years)?” to capture community-acquired pneumonia among children and adolescents. The performance of a chest x-ray alone may be an indicator of severe disease for children and adolescents, but not for adults.	Minimal, <1 minute decrease
Deletion		K. Chest X-ray 2. Were any of these chest x-rays abnormal? 2a. Date of first abnormal chest x-ray 2b. For first abnormal chest x-ray, please check all that apply Justification Previous analyses used these variables along with discharge diagnoses and/or ICD-10 discharge codes to define pneumonia. Given the difficulty in interpreting chest radiograph findings and the ability to capture pneumonia with other data collected from the case report form, questions about abnormal chest x-rays and their interpretation were removed	1-2 minute decrease in burden
Addition		N. Pregnancy Information 5. Pregnancy complications during current pregnancy? (Select all that apply) None Pre-eclampsia Intrauterine growth restriction (IUGR) Gestational diabetes Pregnancy-induced hypertension (PIH) Unknown Justification Added question to better characterize pregnancy complications with respiratory infection	Minimal, <1 minute increase
Addition		R. COVID-19 Vaccine History Vaccine registry: Registry reviewed Registry available but not reviewed (specify) Registry not available for review Dose Date Dose Product: Pfizer-BioNTech COVID-19 Vaccine Moderna COVID-19 Vaccine Jansen Pharmaceuticals Novavax COVID-19 Vaccine AstraZeneca Unknown Other, specify Dose Source: Registry Justification: FluSurv-NET added these new optional fields in participating states where state vaccine registries or immunization information systems are reliable to collect variables related to COVID-19 vaccination status. Similar variables were previously OMB-approved and collected during the 2022-23 season. These fields are currently being extracted from immunization information systems for COVID-19-associated hospitalizations for 2023-24 season in the COVID-NET surveillance platform and used for FluSurv-NET so burden is not impacted. These data elements were added to better understand the association between receipt of COVID-19 and influenza vaccination among influenza hospitalizations. Additionally, collecting COVID-19 vaccination status on FluSurv-NET cases can be explored as an indicator to impute for missing influenza vaccination for analyses. If these elements related to COVID-19 vaccination are beneficial in imputing missing influenza vaccination status and registries remain a reliable source for COVID-19 vaccination, these elements could be collected in lieu of conducting provider and patient/proxy interviews to ascertain influenza vaccination status, which would reduce burden on respondents.	None to minimal; data extracted from state immunization registries and linked for FluSurv-NET cases
Phone Script and Consent Form (FSN.300.2)
Revision		Race and/or Ethnicity (select all that apply) American Indian or Alaska Native Asian Black or African American Hispanic or Latino Middle Eastern or North African Multiracial, not otherwise specified Native Hawaiian or Pacific Islander White Unknown Justification Due to change in OMB standards, race and ethnicity questions were combined into a question and allowed for all that applied to be selected. A new category for “Middle Eastern or North African” was added. Although the OMB standards include a “Not specified” category, this was revised to be “Unknown” to be consistent with past approved case report forms and an “unknown” option is used for almost all other variables and is needed for data cleaning and analysis purposes. OMB standards do not include “Multiracial, not otherwise specified”, but this category will be kept for consistency with previous seasons and situations where medical charts do not specify additional details about multirace. This is not a change and does not impact burden Race/ethnicity will be collected through the minimum categories for the 2024-2025 season, rather than the expanded categories, with the following justification: Detailed data collection would potentially be more burdensome for the surveillance staff and may not add as much value, given that the additional check boxes will likely have few case counts There will not likely be sufficient number of cases identified to allow the disaggregated racial/ethnic categories to be analyzed separately; any analysis performed will probably require aggregating the data into the minimum required categories FluSurv-NET data collection is primarily conducted through medical record reviews and not through patient interviews. The detailed data collection seems to be more intended for interviews rather than chart reviews. The detailed race/ethnicity population groups likely comprise a small percentage of our surveillance catchment areas and the collection of these groups could pose additional risk to data privacy and identification of individuals	Minimal, <1 minute increase
Revision		Updated Spanish translation consent forms and phone scripts to reflect the new race and/or ethnicity question	No change to burden
Provider Vaccination History Fax Form (FSN.300.3)
Revision		Race and/or Ethnicity (select all that apply) American Indian or Alaska Native Asian Black or African American Hispanic or Latino Middle Eastern or North African Multiracial, not otherwise specified Native Hawaiian or Pacific Islander White Unknown Justification Due to change in OMB standards, race and ethnicity questions were combined into a question and allowed for all that applied to be selected. A new category for “Middle Eastern or North African” was added. Although the OMB standards include a “Not specified” category, this was revised to be “Unknown” to be consistent with past approved case report forms and an “unknown” option is used for almost all other variables and is needed for data cleaning and analysis purposes. OMB standards do not include “Multiracial, not otherwise specified”, but this category will be kept for consistency with previous seasons and situations where medical charts do not specify additional details about multirace. This is not a change and does not impact burden Race/ethnicity will be collected through the minimum categories for the 2024-2025 season, rather than the expanded categories, with the following justification: Detailed data collection would potentially be more burdensome for the surveillance staff and may not add as much value, given that the additional check boxes will likely have few case counts There will not likely be sufficient number of cases identified to allow the disaggregated racial/ethnic categories to be analyzed separately; any analysis performed will probably require aggregating the data into the minimum required categories FluSurv-NET data collection is primarily conducted through medical record reviews and not through patient interviews. The detailed data collection seems to be more intended for interviews rather than chart reviews. The detailed race/ethnicity population groups likely comprise a small percentage of our surveillance catchment areas and the collection of these groups could pose additional risk to data privacy and identification of individuals	Minimal, <1 minute increase
Revision		Supplemental language was added in form of a notification letter that sites may mail to the patient/proxy prior to the patient interview notifying that the patient/proxy will be contacted by their state health department to obtain influenza vaccination status only. The supplemental document will not collect any data or information from the patient. Justification Patient/proxy outreach to obtain influenza vaccination history is burdensome and often result in non-responsiveness, with patients not picking up phone calls from numbers they do not know or hang-up during the patient interview. No responses from patient interview yield unknown vaccination status, which impacts reported influenza vaccination rates. Advanced notice via a mailed letter to patients/proxies of an upcoming phone call may reduce the burden for follow-up.	No changes to burden
FluSurv-NET Laboratory Survey (FSN.300.4)
Addition		Title Justification Added field for the title of the person completing the survey	Minimal, <1 minute increase
Revision		Select the kit name(s) (manufacturer) for the rapid influenza antigen diagnostic test(s) performed or planned to be used at the laboratory Acucy Influenza BA&B Test BD Veritor System for Rapid Detection of Flu A+B (CLIA-waived) BD Verirot System for Rapid Detection of Flu A+B (Moderately Complex) BD Veritor System for Rapid Detection of SARS-CoV-2 Binax NOW Influenza A&B Card 2 BioSign Flu A+B or LifeSign LLC Status Flu A & B CareStart Flu A&B Plus Meridian Bioscience ImmunoCard STAT Flu A&B OSOM Ultra Plus Flu A&B Test (Sekisui Diagnostics, LLC) QuickVue Influenza A+B Test SARS-CoV-2 & Flu A.B Rapid Antigen Test SEKISUI Diagnostics OSOM Ultra Plus Flu A and B Test Kit Sofia Analyzer and Influenza A+B FIA (CLIA-waived) Sofia Analyzer and Influenza A+B FIA Sofia 2 Flu + SARS Antigen FIA Sure-Vue Signature Influenza A and B Test Kit XPECT Influenza A/B Justification Added new kits and removed kits that no longer exist	Minimal, <1 minute increase
Revision		Select kit name(s) (manufacturer) for all molecular assays performed or planned to be used at the laboratory: (Check all that apply) Alinity M Resp-4 Plex Assay (Abbott) Aptima SARS-CoV-2/Flu/A/B‡ (Hologic) ARIES® Flu A/B & RSV+SARS CoV 2 Assay (Diasorin) BioCode® CoV-2 Flu Plus Assay (Applied BioCode Inc) BioCode Respiratory Pathogen Panel, (Applied BioCode Inc) BioFire FilmArray Pneumonia (PN) Panel (Biomerieux) BioFire FilmArray Pneumonia plus (PNplus) Panel (Biomerieux) BioFire Respiratory Panel 2.1 (RP2.1) (Biomerieux) BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) (EUA) (Biomerieux) CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (Influenza B Lineage Genotyping Kit), (CDC Influenza Division) CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (Influenza A Subtyping Kit), (CDC Influenza Division) CDC Influenza A/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set, (CDC Influenza Division) CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (Influenza A/B Typing Kit), (CDC Influenza Division) CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay (CDC Influenza Division) Cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test, (Roche Diagnostics) ePlex Respiratory Pathogen Panel 2, (Roche Diagnostics) Lyra Influenza A+B Assay, (Quidel) NeuMoDX Influenza A/B, RSV, and SARS-CoV-2 Vantage Assay (Qiagen) Nx-TAG Respiratory Pathogen Panel, (Diasorin) Nx-TAG Respiratory Pathogen Panel + SARS-CoV-2 (Diasorin) Panther Fusion® Flu A/B RSV, (Assay Hologic) Panther Fusion SARS-CoV-2/Flu A/B/RSV assay QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAGEN) Quest Diagnostics RC COVID-19 +Flu RT-PCR, (Quest Diagnostics) RealStar Influenza Screen & Type RT-PCR Simplexa™ COVID-19 & Flu A/B Direct Simplexa™ Flu A/B & RSV Direct Gen II (Diasorin) Solana Influenza A+B Assay, (Quidel) Solana Respiratory Viral Panel (Quidel) Verigene® Respiratory Pathogen Nucleic Acid Test (RP Flex), (Luminex) Justification Added new kits and removed kits that no longer exist	Minimal, <1 minute increase

HAIC:

This Revision includes proposed changes to 5 of 13 approved Healthcare-Associated Infections – Community Interface (HAIC) data collection tools (form/s) detailed below.  There are no new collection tools for HAIC.  

Approved Forms with no changes noted:

1. HAIC.400.2 MuGSI CA CP-CRE Health interview  

2. HAIC.400.7 CDI Case Report and Treatment Form 

3. HAIC.400.8 Annual Survey of Laboratory Testing Practices for C. difficile Infections 

4. HAIC.400.9 CDI Annual Surveillance Officers Survey 

5. HAIC.400.10 C. difficile Surveillance Nursing Home Telephone Survey (LTCF) 

6. HAIC.400.11 Candidemia Case Report Form 

7. HAIC.400.12 Laboratory Testing Practices for Candidemia Questionnaire 

8. HAIC.400.13 Death Ascertainment Project  

Changes to Approved Forms: 

1. HAIC.400.1 Multi-site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form

2. HAIC.400.3 MuGSI Supplemental Surveillance Officer Survey  

3. HAIC.400.4 Invasive Staphylococcus aureus Infection Case Report Form   

4. HAIC.400.5 Invasive Staphylococcus aureus Laboratory Survey 

5. HAIC.400.6 Invasive Staphylococcus aureus Supplemental Surveillance Officer Survey 

Multi-site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form (HAIC.400.1)  

Type of Change 

Itemized Changes / Justification 

Impact to Burden 

 Correction

For the MuGSI CRF there has been an increase in the number of respondents (from 10 to 11), however, an error was identified in how the number of responses per respondent was previously reported. This has resulted in reduction from 4,770 to 1,581 responded per respondent. While the Avg. burden per response increase from 28 to 29 minutes, there was a decrease in the Current Total burden (in hours) from 21,922 to 8,406. 

Decrease 

Addition 

20. Risk factors: (Check all that apply) 

Invasive or diagnostic urologic procedure in the year before DISC: 

ð Yes  ð No  ð Unknown 

If yes, check all that apply: 

ð Prostate procedure  ð Cystoscopy ð Other 

Justification:

• Added a risk factor response option for “Invasive or diagnostic urologic procedure”. Recent literature identified a greater risk for invasive E. coli disease in hospitalized patients with a recent diagnostic or interventional medical procedure. Vaccination of patient groups with anticipated urologic diagnostic or invasive procedures have been proposed as an intervention. The addition of this new risk factor questions allows us to establish baseline surveillance for these procedures associated with E. coli disease. This information is located in the sections of the medical record that are reviewed for other risk factor responses. 

0.5 minute increase. 

Addition/ Revision 

23b. Risk factors prior to CRAB DISC: 

ð Non-invasive positive pressure ventilation (CPAP or BiPAP) at any time in the 7 calendar days before the DISC 

ð Nebulizer treatment at any time in the 7 calendar days before the DISC 

ð Mechanical ventilation at any time in the 7 calendar days before the DISC  

ð Visited a wound care clinic at any time in the year before the DISC 

ð None 

 

• Removed the qualifier “…in the 7 days before the DISC” from the question prompt of Q23b and added them to the response options. 

Justification:

• Addition of a risk factor beyond that timeframe. This additional risk factor option allows for accurately classifying CRAB cases by their exposure, that would otherwise be misclassified. This information is located in the sections of the medical record that are reviewed for other risk factor responses. 

 

0.5-minute increase  

Multi-site Gram-negative Surveillance Initiative (MuGSI) Supplemental Surveillance Officer Survey (HAIC.400.3)

Type of Change 

Itemized Change / Justification 

Impact to Burden 

Revision 

Site: ___ CA ___ CO ___ CT ___ GA  ___ MD ___ MI___ MN ___ NM ___ NY ___ OR ___ TN 

Justification:

• Michigan is participating in MuGSI invasive Escherichia coli surveillance activity in 2024, “MI” has been included as a response.  

No changes to burden 

Revision 

Surveillance area characteristics: 

1. What counties are under surveillance for MuGSI activities at your site? 

1. Carbapenem-resistant Enterobacterales (CRE) surveillance area, please specify: 

2. Carbapenem-resistant Acinetobacter baumannii (CRAB) surveillance area, please specify: 

3. Extended-spectrum β-lactamases-producing Enterobacterales (ESBL-E) surveillance area, please specify:  

4. Invasive Escherichia coli (iEC) surveillance area, please specify: 

 Justification:

• Surveillance for invasive Escherichia coli began in 2024, included a response “d. Invasive Escherichia coli (iEC) surveillance area, please specify” to this existing question. 

Increase in burden 

Addition/ Revision 

Surveillance area characteristics: 

2. Is CRE reportable at your state/site?  ___ yes ___ no 

1. If yes: 

1. Please describe your state reportable definition of CRE:______________  

2. Where in your state is CRE reportable? 

_______ Statewide  

_______ Defined area, such as a county(ies). Please specify 

3. Is isolate submission to the State Health Department Laboratory required? 

_______ yes _______ no    specify _____ 

2. If no: 

1. What mechanism do you have in place that allows for surveillance officers (SOs) to have access to CRE laboratory reports and medical records? 

_______ Agent of the state 

_______ State Health Department Regulation 

_______ Other, please explain: _____________ 

2. Does your state/site plan to make CRE reportable?  ___ yes___ no ___ unknown 

1. If yes, when does your state/site plan to make CRE reportable?  

 

• Minor word changes and included an “unknown” response option and one clarifying question “if yes, when does your state/site plan to make CRE reportable?”  

No changes to burden. 

Addition/ Revision 

Surveillance area characteristics: 

3. Is CRAB state reportable at your site?  ___ yes___ no 

1. If yes: 

1. Please describe your state reportable definition of CRAB:______________  

2. Where in your state is CRAB reportable? 

_______ Statewide  

_______ Defined area, such as a county(ies). Please specify 

3. Is isolate submission to the State Health Department Laboratory required? 

_______ yes _______ no    specify _____ 

2. If no: 

1. What mechanism do you have in place that allows for surveillance officers (SOs) to have access to CRAB laboratory reports and medical records? 

_______ Agent of the state 

_______ State Health Department Regulation 

_______ Other, please explain: _____________ 

2. Does your state/site plan to make CRAB reportable?  ___ yes___ no ___ unknown 

1. If yes, when does your state/site plan to make CRAB reportable?________  

• Minor word changes and included an “unknown” response option and one clarifying question “If yes, when does your state/site plan to make CRAB reportable?”. 

No changes to burden. 

Addition/ Revision 

Surveillance area characteristics: 

4. Is ESBL-E reportable at your state/site?  ___ yes ___ no 

1. If yes: 

1. Please describe your state reportable definition of ESBL-E:______________  

2. Where in your state is ESBL-E reportable? 

_______ Statewide  

_______ Defined area, such as a county(ies). Please specify 

3. Is isolate submission to the State Health Department Laboratory required? 

_______ yes _______ no     specify _____ 

2. If no: 

1. What mechanism do you have in place that allows for surveillance officers (SOs) to have access to ESBL-E laboratory reports and medical records? 

_______ Agent of the state 

_______ State Health Department Regulation 

_______ Other, please explain: _____________ 

2. Does your state/site plan to make ESBL-E reportable? ___ yes ___ no ___ unknown 

1. If yes, when does your state/site plan to make ESBL-E reportable?  

 

• Minor word changes and included an “unknown” response option and one clarifying question “If yes, when does your state/site plan to make ESBL-E reportable”. 

No change to burden. 

Revision 

Surveillance area characteristics: 

5. Is iEC reportable at your state/site?  ___ yes ___ no 

1. If yes: 

1. Please describe your state reportable definition of iEC:______________  

2. Where in your state is iEC reportable? 

_______ Statewide  

_______ Defined area, such as a county(ies). Please specify 

3. Is isolate submission to the State Health Department Laboratory required? 

_______ yes _______ no   specify ______ 

2. If no: 

1. What mechanism do you have in place that allows for surveillance officers (SOs) to have access to iEC laboratory reports and medical records? 

_______ Agent of the state 

_______ State Health Department Regulation 

_______ Other, please explain: _____________ 

2. Does your state/site plan to make iEC reportable?___ yes___ no ___ unknown 

1.If yes, when does your state/site plan to make iEC reportable? 

Justification:

• Surveillance for invasive Escherichia coli (iEC) began in 2024, included the corresponding questions that are asked for the other MuGSI surveillance activities. This information is readily available to the EIP site respondent.    

Increase in burden 

Revision 

Laboratory Participation and Isolate Testing – Part 1 

1. Please describe the clinical laboratories in the MuGSI catchment area: 

1. CRE 

1. Proportion of clinical laboratories serving the MuGSI CRE surveillance area with queries installed on their automated testing instrument (ATI) or laboratory information system (LIS): ___________________ 

2. Numerator: Number of clinical laboratories serving the MuGSI CRE surveillance area with queries installed on their ATI or LIS: ___________________ 

3. Denominator: Total number of clinical laboratories that receive and process specimens from residents of the MuGSI CRE surveillance area:______________ 

4. Please describe how MuGSI CRE surveillance is conducted at laboratories where ATI/LIS queries are not installed (e.g., HL7 messages from LabCorp): __________________________________________________________________ 

2. CRAB 

1. Proportion of clinical laboratories serving the MuGSI CRAB surveillance area with queries installed on their ATI or LIS: ___________________ 

2. Numerator: Number of clinical laboratories serving the MuGSI CRAB surveillance area with queries installed on their ATI or LIS: _________________ 

3. Denominator: Total number of clinical laboratories that receive and process specimens from residents of the MuGSI CRAB surveillance area: _____________ 

4. Please describe how MuGSI CRAB surveillance is conducted at laboratories where ATI/LIS queries are not installed (e.g., HL7 messages from LabCorp): __________________________________________________________________ 

3. ESBL-E 

1. Proportion of clinical laboratories serving the MuGSI ESBL-E surveillance area with queries installed on their ATI or LIS: ___________________ 

2. Numerator: Number of clinical laboratories serving the MuGSI ESBL-E surveillance area with queries installed on their ATI or LIS: _________________ 

3. Denominator: Total number of clinical laboratories that receive and process specimens from residents of the MuGSI ESBL-E surveillance area:____________ 

4. Please describe how MuGSI ESBL-E surveillance is conducted at laboratories where ATI/LIS queries are not installed (e.g., HL7 messages from LabCorp): __________________________________________________________________ 

4. iEC 

1. Proportion of clinical laboratories serving the MuGSI iEC surveillance area with queries installed on their ATI or LIS: ___________________ 

2. Numerator: Number of clinical laboratories serving the MuGSI iEC surveillance area with queries installed on their ATI or LIS: ___________________ 

3. Denominator: Total number of clinical laboratories that receive and process specimens from residents of the MuGSI iEC surveillance area:______________ 

4. Please describe how MuGSI iEC surveillance is conducted at laboratories where ATI/LIS queries are not installed (e.g., HL7 messages from LabCorp): _________________________________________________________________ 

 Justification:

• Minor word changes for clarification. Included corresponding questions for invasive Escherichia coli under “d. iEC” as surveillance began in 2024. 

Increase in burden 

Addition 

Laboratory Participation and Isolate Testing – Part 1 

2. Did any laboratories drop out of participation in 2023?     _______ yes _______ no 

1. If yes, how many? _________ 

2. Why did these laboratories drop out of participation? 

__________________________________________________________________________________________________________________________________________ 

Justification:

• Added this question to clarify participation of local clinical laboratories surveillance activities in case any are no longer able to participate.  

Increase in burden 

Addition 

Laboratory Participation and Isolate Testing – Part 1 

3. In 2023, did you identify additional laboratories, regardless of location, which identify MuGSI isolates from persons who are residents of the MuGSI surveillance area at your site? 

_______ yes _______ no 

1. If yes, how many? _________ 

2. If yes, how many of these laboratories were added? __________________________________________ 

1. If all new laboratories identified were not added, why not? __________________________________________________________________ 

__________________________________________________________________ 

3. If yes, how did you identify these new laboratories? 

_____________________________________________________________________ 

4. Approximately how many cases are identified at the new laboratories each year among residents of the MuGSI surveillance area? ________ 

 Justification:

• Added this question to clarify participation of local clinical laboratories in MuGSI surveillance activities in case any new laboratories recently enrolled. 

Increase in burden 

Revision 

Laboratory Participation and Isolate Testing – Part 1 

4. Did your site send any MuGSI isolates to CDC for characterization in calendar year 2023?                             _______ yes _______ no  

1. If yes, please describe how your site determines which MuGSI isolates to send to CDC: 

1. CRE: ____________________________________ 

2. CRAB: ___________________________________ 

3. ESBL: ____________________________________ 

4. iEC: ____________________________________ 

2. If yes, how many clinical laboratories contributed MuGSI isolates: 

1. CRE: ____________________________________ 

2. CRAB: ___________________________________ 

3. ESBL: ____________________________________  

4. IEC: 

____________________________________ 

 

Justification:

• Minor word changes for clarification. Since surveillance began for invasive Escherichia coli began in 2024, included “iEC” response options.  

Increase in burden 

Revision 

Laboratory Participation and Isolate Testing – Part 1 

5. How many isolates with a specimen collection date in 2023 did you expect to be able to collect from the clinical laboratories?  

_______ CRE; _______ CRAB; _______ ESBL; ________iEC 

 

Justification:

• Minor word changes for clarification. Since surveillance began for invasive Escherichia coli began in 2024, included an “iEC” response option. 

Increase in burden 

Revision 

Laboratory Participation and Isolate Testing – Part 1 

6. What was the total number of isolates with a specimen collection date in 2023 that were collected from the clinical laboratories _______ CRE; _______ CRAB; _______ ESBL; _______iEC 

 

Justification:

• Minor word changes for clarification. Since surveillance began for invasive Escherichia coli began in 2024, included an “iEC” response option. 

Increase in burden 

Revision  

Laboratory Participation and Isolate Testing – Part 2 

2. Type of laboratory:  

_____clinical laboratory  

_____public health laboratory 

_____research laboratory  

_____reference laboratory 

Justification:

• Included response options, rather than a free-text field, for an existing question. 

No change in burden. 

Revision 

Laboratory Participation and Isolate Testing – Part 2 

3. MuGSI pathogen(s) under surveillance:  

_____CRE  

_____CRAB  

_____ESBL  

_____iEC 

Justification:

• Included response options, rather than a free-text field, for an existing question. 

No change in burden. 

Addition 

Laboratory Participation and Isolate Testing – Part 2 

4. Method for sharing laboratory reports with your site: 

_____electronic messaging, such as HL7  

_____e-mail  

_____fax  

_____EIP staff manually generate reports on-site  

_____other, please specify__________________ 

_____unknown 

Justification:

• Added this question to clarify how laboratories share information on MuGSI cases with EIP staff. This information is readily available to the EIP site for each laboratory. 

Increase in burden 

Revision 

Laboratory Participation and Isolate Testing – Part 2 

5. Method for case identification: 

_____automated testing instrument  

_____laboratory information system  

_____medical record  

_____other, please specify_____________________  

_____unknown 

Justification:

• Included response options, rather than a free-text field, for an existing question. 

No change in burden 

Revision 

Laboratory Participation and Isolate Testing – Part 2 

7. Carbapenem confirmatory testing method 

1. Please report the carbapenem confirmatory testing method(s) performed for each MuGSI organism separately. 

 

kirby bauer:_____CRE _____CRAB _____ESBL _____iEC 

 

other, please specify: _____CRE _____CRAB _____ESBL  

_____iEC 

 

laboratory not testing _____CRE _____CRAB _____ESBL _____iEC 

 

unknown _____CRE _____CRAB _____ESBL _____iEC 

Justification:

• Included response options, rather than a free-text field, for the existing question. 

No change in burden 

Revision 

Laboratory Participation and Isolate Testing – Part 2 

8. Carbapenemase testing method 

1. Please report the carbapenemase testing method(s) performed for each MuGSI organism separately. 

 

Non-molecular test methods 

carbaNP: _____CRE _____CRAB _____ESBL _____iEC 

 

carbapenemase inactivation method: _____CRE _____CRAB _____ESBL _____iEC 

 

CPO detect: _____CRE _____CRAB _____ESBL _____iEC 

 

disk diffusion/ROSCO disk e-test: _____CRE _____CRAB _____ESBL _____iEC 

 

modified carbapenemase inactivation method: _____CRE _____CRAB _____ESBL _____iEC 

 

modified hodge test: _____CRE _____CRAB _____ESBL _____iEC 

 

RAPIDEC: _____CRE _____CRAB _____ESBL _____iEC 

 

Other, please specify: _____CRE _____CRAB _____ESBL _____iEC 

 

laboratory not testing: _____CRE _____CRAB _____ESBL _____iEC 

 

unknown: _____CRE _____CRAB _____ESBL _____iEC  

Molecular test methods 

automated molecular assay: _____CRE _____CRAB _____ESBL _____iEC 

 

carba-R: _____CRE _____CRAB _____ESBL _____iEC 

 

check points: _____CRE _____CRAB _____ESBL _____iEC 

 

MALDI-TOF MS: _____CRE _____CRAB _____ESBL _____iEC 

 

next generation nucleic acid sequencing: _____CRE _____CRAB _____ESBL _____iEC 

 

polymerase chain reaction: _____CRE _____CRAB _____ESBL _____iEC 

 

streck ARM-D: _____CRE _____CRAB _____ESBL _____iEC 

 

other, please specify:____________________ _____CRE _____CRAB _____ESBL _____iEC 

 

laboratory not testing: _____CRE _____CRAB _____ESBL _____iEC 

 

unknown: _____CRE _____CRAB _____ESBL _____iEC  

 

Justification:

• Included response options, rather than a free-text field, for the existing question. 

No change in burden 

Revision 

Laboratory Participation and Isolate Testing – Part 2 

9. ESBL production testing method  

1. Please report the ESBL production testing method(s) performed for each MuGSI organism separately. 

 

broth microdilution – ESBL well:_____CRE _____CRAB _____ESBL _____iEC 

broth microdilution – ATI flag: _____CRE _____CRAB _____ESBL _____iEC 

broth microdilution – manual: _____CRE _____CRAB _____ESBL _____iEC 

disk diffusion: _____CRE _____CRAB _____ESBL _____iEC 

e-test: _____CRE _____CRAB _____ESBL _____iEC 

molecular test, please specify_____CRE _____CRAB _____ESBL _____iEC 

other non-molecular test, please specify:_____CRE _____CRAB _____ESBL _____iEC 

laboratory not testing: _____CRE _____CRAB _____ESBL _____iEC 

unknown: _____CRE _____CRAB _____ESBL _____iEC 

Justification:

• Included response options, rather than a free-text field, for the existing question. 

No change in burden 

Revision 

Laboratory Participation and Isolate Testing – Part 2 

10. Organism identification method^† 

1. Please report the organism identification method(s) performed for each MuGSI organism separately. 

 

MALDI-TOF: _____CRE _____CRAB _____ESBL _____iEC 

polymerase chain reaction: _____CRE _____CRAB _____ESBL _____iEC 

whole genome sequencing: _____CRE _____CRAB _____ESBL _____iEC 

DNA sequencing, please specify:_____CRE _____CRAB _____ESBL _____iEC 

rRNA gene sequencing, please specify:_____CRE _____CRAB _____ESBL _____iEC 

biochemical tests, please specify:_____CRE _____CRAB _____ESBL _____iEC 

immunological techniques, please specify:_____CRE _____CRAB _____ESBL _____iEC 

other, please specify:_____CRE _____CRAB _____ESBL _____iEC 

laboratory not testing:_____CRE _____CRAB _____ESBL _____iEC 

unknown: _____CRE _____CRAB _____ESBL _____iEC  

Please specify the database or library for the instrument(s) selected above:________________________________________________ 

 

Justification:

• Included response options, rather than a free-text field, for the existing question. 

No change in burden 

Revision 

Laboratory Participation and Isolate Testing – Part 2 

11. Culture-independent diagnostic test: 

      _____yes, please specify the type of test________________ 

                If yes, is a positive test result always followed up by a       

                culture? _______ yes _______ no _______ unknown 

     _____no 

     _____unknown 

 

• Included response options, rather than a free-text field, for the existing question. 

No change in burden 

Revision 

Laboratory Participation and Isolate Testing – Part 2 

12. Isolate submission to state public health laboratory 

_____yes 

_____no 

_____unknown 

Justification:

• Included response options, rather than a free-text field, for the existing question. 

No change in burden 

Addition 

Laboratory Participation and Isolate Testing – Part 2 

13. Most recent year a check-in was completed for the laboratory: _____________________ 

 Justification:

• Added this question which is readily available because EIP staff complete this check-in with each laboratory on an annual basis. 

 

Increase in burden 

Addition 

Laboratory Participation and Isolate Testing – Part 2 

Please describe the participating laboratory’s policy on maximum duration of referral for antimicrobial susceptibility testing for successive isolates of the same MuGSI organism. Successive isolates are defined as two microorganisms with similar identification that was cultured from the same patient at two different time points. Please indicate if the policy differs depending on whether successive isolates were cultured from the same specimen source or different specimen source. _______________________________________ 

 

Justification:

• Added this question for clarification about isolate testing practices at each laboratory, which has implications on MuGSI case reporting. This information is readily available for EIP staff. 

Increase in burden 

Addition 

Additional information on MuGSI surveillance activities 

2. In 2023, did your site update its inventory of facilities within the MuGSI surveillance area? _______ yes    _______ no 

1. If no, why not? 

____________________________________________________________________________________________ 

2. If yes, how many facilities serve the MuGSI surveillance area?  _________ 

3. If yes, how many facilities have you identified the clinical laboratory that serves it?__________ 

 

Justification:

• Added this question for clarification about the facilities participating in MuGSI surveillance activities at the EIP sites. This information should be readily available because EIP staff complete this inventory on an annual basis. 

Increase in burden 

Addition 

Additional information on MuGSI surveillance activities 

3. Does your site run a data edit program in addition to the CDC edit program that is sent out monthly? This could include the data edits available on the MuGSI Case Management System dashboard. 

_______ yes _______ no 

1. If yes, how often: 

_______ Monthly  

_______ Quarterly 

_______ Other time frame, specify: ______________________________________ 

_______ Never 

2. If yes, what type of edits are you running? Do you think they would be helpful to add to edits generated by CDC? ________________________ 

 Justification:

• Added this question for clarification about data cleaning at the EIP sites. This information should be readily available for EIP staff since it relates to their routine roles and responsibilities. 

Increase in burden 

Addition 

Additional information on MuGSI surveillance activities 

4. Did your site geocode MuGSI cases in 2023?                            _____ yes     ______ no 

      a.  If yes, what is the most recent year of surveillance data that was geocoded? ___________________  

b. If no, why not? 

Justification:

• Added this question for clarification about MuGSI cases being geocoded, which is required on an annual basis, so this information is readily available for EIP staff. 

Increase in burden 

Addition 

Additional information on MuGSI surveillance activities 

5. Did your site match MuGSI cases to the state vital statistics death registry in 2023?    _____ yes     ______ no 

1. If yes, what is the most recent year of surveillance data that was matched?___________________ 

2. If no, why not? _________________________________ 

 Justification:

• Added this question for clarification about MuGSI cases being matched to the state vital statistics death registry, which is required on an annual basis, so this information is readily available for EIP staff. 

Increase in burden 

Addition 

Additional information on MuGSI surveillance activities 

6. Did your site complete CRF re-abstractions in 2023?            _____ yes     ______ no 

1. If yes, what was the most recent year of surveillance data with CRFs re-abstracted? __________________ 

2. If no, why not? ________________________________ 

 Justification:

• Added this question for clarification about MuGSI chart re-abstractions, which is required on an annual basis, so this information is readily available for EIP staff. 

Increase in burden 

Revision 

Additional information on MuGSI surveillance activities 

7. What is the IRB determination for MuGSI at your site? ____Research   ____Non-Research  ____Other ____Unknown 

 Justification:

• Justification: Included a response option for this existing question, instead of the previous free-text response. 

No change in burden 

Addition 

Additional information on MuGSI surveillance activities 

8. General comments_________________________________ 

 Justification:

• Added a free-text field for any general comments related to the information collected on the survey. 

No change in burden. 

Invasive Staphylococcus aureus Healthcare-Associated Infections Community Interface Case Report Form (HAIC.400.4)

Type of Change 

Itemized Changes / Justification 

Impact to Burden 

Addition/Revision 

22.  SUSCEPTIBILITY RESULTS (S=Sensitive (1), I=Intermediate (2), R=Resistant (3), NS=Non-susceptible (4), SDD=Susceptible dose-dependent (5), U=Unknown/Not Reported (9) 

Cefazolin   □S  □I □R □U	Cefoxitin   □S  □R □U	Ceftaroline  □S  □SDD □R □U	Clindamycin   □S  □I □R □U
Daptomycin   □S  □I □R □U	Doxycycline  □S  □I □R □U	Linezolid  □S  □R □U	Nafcillin   □S  □I □R □U
Oxacillin   □S  □R □U	Tetracycline  □S  □I □R □U	TMP-SMX  □S  □I □R □U	Vancomycin   □S  □I □R □U

Justification:

• Added antimicrobial agents “Daptomycin”, “Doxycycline”, “Ceftaroline”,  “Linezolid”, and “Tetracycline” as these drugs are commonly used to treat  S. aureus infections; isolates are often tested for susceptibilities to these drugs but the information is not currently captured in our surveillance.  Inclusion of these additional relevant drugs in surveillance is important for understanding and following invasive S. aureus resistance patterns over time. 

• Updated wording of one antimicrobial agent from “Trimethoprim-sulfamethoxazole” to “TMP-SMX”, a commonly used abbreviation 

0.5-minute increase 

Addition 

28a.  Does the patient have (check all that apply)		If yes, is it associated with the MRSA/MSSA infection?
Implanted cardiac device (e.g., prosthetic heart value, pacemaker, AICD, LVAD)	□Yes, specify:___  □No  □Unknown	□Yes  □No  □Unknown
Implanted orthopedic device (e.g., prosthetic joint or orthopedic hardware?	□Yes, specify:___  □No  □Unknown	□Yes  □No  □Unknown
Non-dialysis vascular graft	□Yes                      □No  □Unknown	□Yes  □No  □Unknown
Justification:  S. aureus is an important cause of implanted device-associated infections; these questions will allow us to better describe and quantify infections related to implanted devices

 

0.5-minute increase 

Addition 

28b.  Does the patient have another type of implanted prosthetic device that was associated with the infection? 

□ Yes, specify:_____________  □ No  □ Unknown 

Justification:

• Many invasive S. aureus infections are associated with implanted devices; these questions will allow us to better describe and quantify infections related to implanted devices 

Increase 

Revision 

29. □ Transplant, solid organ:_______ 

Justification:

• A specify box has been added to the CRF to capture the solid organ that was transplanted (for instances where the patient had a solid organ transplant). 

• This information was previously captured in the “general comments” section of the form 

No change to burden 

Invasive Staphylococcus aureus Laboratory Survey  (HAIC.400.5) 

Type of Change 

Itemized Change / Justification 

Impact to Burden 

Revision 

CDC’s Healthcare-Associated Infections Community Interface (HAIC) Staphylococcus aureus 2024 Laboratory Survey: Use of Nucleic Acid Amplification Testing (NAAT). 

• Updated the title of the survey by replacing “2023” with “2024” 

Justification:

• This will inform respondents to the year of interest 

No change in burden 

Addition 

Date Survey Last Completed: ___________ 

• Adding a field “Date Survey Last Completed” 

Justification:

• This will define the time-period since the last survey, which will serve as a frame of reference for question 2 

Increase 

Revision/Addition 

5b.  Which tests do you use to detect S. aureus directly from a sterile site source without culture (sterile site sources only, i.e., blood, CSF, pleural fluid, bone, etc.)? Please check all that apply. 

□ T2Bacteria® Panel…Date started ______ 

□ Other FDA-approved test, specify___ Date started __ 

Method: □ PCR □ Next generation sequencing (NGS) 

□ Other, specify __________ 

□ Karius Test^TM… Date started______ 

□ Other, Lab developed test (detects MRSA or SA)… Date started _ 

Method: □ PCR □ Next generation sequencing (NGS) 

□ Other, specify __________ 

Justification:

• Changed the wording for one option from “Other commercial test, specify” to “Other FDA-approved test, specify” to help clarify what we are asking 

• Added follow-up questions for labs using Other FDA approved tests and/or other lab developed tests to capture the testing method being used.  This will contribute to a better understanding of how labs are identifying S. aureus 

Increase 

Revision 

5g.  Where do you plan to have these tests performed? 

□ On-site   

□ Send out, please specify lab _______ - END SURVEY 

• Added a skip pattern (“END SURVEY”) 

No change in burden 

Addition 

5h.  Which tests do you plan to use to detect S. aureus directly from a sterile site source without culture? (sterile site sources only, i.e., blood, CSF, pleural fluid, bone, etc.)? Please check all the apply. 

□ T2Bacteria® Panel…Date started ______ 

□ Other FDA-approved test, specify___ Date started __ 

□ Karius Test^TM… Date started______ 

□ Other, Lab developed test (detects MRSA or SA)… Date started _ 

5i.  Will all positive tests directly from sterile sources (without positive culture) appear in the S. aureus surveillance laboratory line lists? 

 □ Yes □ No □ Unknown 

 

5j.  Will you still obtain an isolate for S. aureus or MRSA if these tests are used? 

□ Yes-END SURVEY □ No-END SURVEY □ Unknown – END SURVEY 

Justification:

• Added to understand how commonly culture-independent tests are used for detecting invasive S. aureus and whether these isolates are being reported to surveillance, either through appearance of the culture-independent test in the surveillance laboratory line lists or through existing isolate-based reporting. This information can inform estimates of potential underreporting of cases to isolate based surveillance.  

0.5-minute increase 

Invasive Staphylococcus aureus Supplemental Surveillance Officer Survey (HAIC.400.6) 

Type of Change 

Itemized Change / Justification 

Impact to Burden 

Revision 

2023 HAIC Invasive Staphylococcus aureus Supplemental Surveillance Officer Survey 

• Updated the title of the survey by replacing “2022” with “2023” 

Justification:

• This will inform respondents to the year of interest 

No change to burden 

Revision 

Please answer the following questions for the year 2023. The purpose of the survey is to verify and document current surveillance procedures, including cases ascertainment and auditing methods. Please enter your responses into the corresponding REDCap database.  If you have any questions, please contact Kelly Jackson ([email protected]). 

• Updated the introductory text of the survey by replacing “2022” with “2023” 

Justification:

• This will inform respondents to the year of interest 

No change to burden 

Revision 

Surveillance area characteristics 

 

2. Did your site send MRSA/MSSA isolates to CDC for characterization in 2023?  ___yes  ____no 

 

• Updated the question text by replacing “2022” with “2023”

Justification:

 

• This will inform respondents to the year of interest 

No change to burden 

Revision 

Surveillance area characteristics 

5a.  If yes: 

9. Please mark which NHSN data your site can access 

        _______ Hospital MRSA LabID event 

        _______ Hospital central line-associated bloodstream    infection (CLABSI) data 

        _______ Hospital Antimicrobial Use and Resistance (AUR) Option 

        _______ Dialysis event 

• Added a checkbox for “Hospital Antimicrobial Use and Resistance (AUR) Option” 

Justification:

• This will allow us to better identify if sites are able to obtain this NHSN data that could be used to supplement EIP surveillance data in future analyses. 

No change to burden 

Revision 

Surveillance area characteristics 

5b. If no: 

9. Please mark which NHSN data can be accessed 

        _______ Hospital MRSA LabID event 

        _______ Hospital CLABSI data 

        _______ Hospital AUR Option 

        _______ Dialysis event 

• Added a checkbox for “Hospital AUR Option” 

Justification:

• This will allow us to better identify if sites are able to obtain this NHSN data that could be used to supplement EIP surveillance data in future analyses. 

No change in burden 

Revision 

Lab Participation and Case Finding 

Please answer the following questions for hospitals and labs under surveillance for 2023. 

• Updated the introductory text to the “Lab Participation and Case Finding” section by replacing “2022” with “2023” 

Justification:

• This will inform respondents to the year of interest 

No change in burden 

Revision 

Lab participation and case finding 

1. Please list the total number of each type of lab serving (i.e., routinely processes “sterile site” specimens from residents of the surveillance area) your MRSA surveillance catchment area (both inside and outside of the catchment area) and the total number of each type of lab participating (i.e., submit test results when available) in surveillance (both inside and outside the catchment area): 

 

• Added “i.e., routinely process “sterile site” specimens from residents of the surveillance area” prior to “your MRSA surveillance catchment area” and following “lab serving” 

Justification:

• This wording was added to improve clarity of the question 

No change in burden 

Revision 

Lab participation and case finding 

2. If different catchment that MRSA, please list the total number of each type of lab serving (i.e., routinely processes “sterile site” specimens from residents of the surveillance area) your MSSA surveillance catchment area (both inside and outside of the catchment area) and the total number of each type of lab participating (i.e., submit test results when available) in surveillance (both inside and outside the catchment area): 

 

• Added “i.e., routinely process “sterile site” specimens from residents of the surveillance area” prior to “your MSSA surveillance catchment area” and following “lab serving”

Justification:

 

• This wording was added to improve clarity of the question 

No change in burden 

Revision 

Lab participation and case finding 

4. Indicate the percentage contribution of each case finding method to your site’s total SA case counts (100%) in 2023. 

Case Finding Method used?	% MSSA Case Count Contribution	% MRSA Case Count Contribution	Method
□ Y  □ N			NETSS/NEDSS or other passive state reporting system
□ Y  □ N			Routinely received line lists from hospital labs
□ Y  □ N			Routinely received line lists from Commercial/outpatient labs
□ Y  □ N			Routinely received line lists from dialysis referral labs
□ Y  □ N			Regular lab visits; frequency: ________
□ Y  □ N			ICPs submitting case report form
□ Y  □ N			Isolates being received at state lab
□ Y  □ N			NHSN
□ Y  □ N			Other, please specify: __________

1. Do you expect this distribution and/or percentage values to change in 2024?  

_______ yes _______ no 

i. If yes, please explain why: _________ 

 

• Updated the text of question 4 to replace “2022” with “2023” 

• This will inform respondents to the year of interest 

• Updated the text of the second method listed from “Retrospective review of received line lists from hospital labs” to “Routinely received line lists from hospital labs”  

• This wording was updated to improve clarity of the question 

• Updated the text of question 4a to replace “2023” with “2024” 

• This will inform respondents to the year of interest 

No change in burden 

Revision 

Lab participation and case finding 

5. For labs reporting invasive SA, how many of the participating labs are providing case reports through direct electronic messaging, such as HL7 messaging? ________ 

a.  If less <100%, how else are you receiving reports (check all that apply)?  

□ Secure email 

□ Fax 

□ Manual surveillance on-site 

□ Mailed hard copies 

□ State electronic reporting system 

□ Other, specify: _____________________________ 

 

• Updated question 5a to add “check all that apply” 

• Updated the response type from a free text response to checkboxes 

Justification:

• Replacing free text field with checkboxes will make data entry and analysis easier 

No change in burden 

Revision/Addition 

Lab participation and case finding 

6. Did any labs drop out of participation in 2023? 

_______ yes _______ no 

a.  If yes, how many? _______ 

b.  Why did these labs drop out of participation?__________ 

c.  Approximately how many cases did this/these lab(s) identify each year among residents of your catchment area? 

 

• Updated the text of question 6 to replace “2022” with “2023” 

• This will inform respondents to the year of interest 

• Added question 6c, “Approximately how many cases did this/these lab(s) identify each year among residents of your catchment area” 

• This will allow us to estimate the impact of non-participating labs on yearly case counts 

0.5-minute increase 

Revision 

Lab participation and case finding 

7.  In 2023, did you identify any additional labs, regardless of location, which identify invasive SA isolates from persons who are residents of your catchment area? 

_______ yes _______ no 

• Updated the text of question 7 to replace “2022” with “2023” 

Justification:

• This will inform respondents to the year of interest 

No change in burden 

Revision 

Data Edits 

2. Did your site complete CRF re-abstractions during 2023?   ___ yes     ____ no 

• Updated the text of question 2 to replace “2022” with “2023” 

Justification:

• This will inform respondents to the year of interest 

No change in burden 

Revision 

Ascertainment of surveillance area and case audits 

1.  How did your site define an audit case in 2023? 

• Updated the text of question 1 to replace “2022” with “2023”

Justification:

 

• This will inform respondents to the year of interest 

No change in burden 

Revision 

Ascertainment of surveillance area and case audits 

2. Indicate the percentage contribution of each finding method to your site’s audit counts (100%) in 2023 

Audit Method used?	% MSSA Audit Count Contribution	% MRSA Audit Count Contribution	Method
□ Y  □ N			NETSS/NEDSS or other passive state reporting system
□ Y  □ N			Routinely received line lists from hospital labs
□ Y  □ N			Routinely received line lists from Commercial/outpatient labs
□ Y  □ N			Routinely received line lists from dialysis referral  labs
□ Y  □ N			Regular lab visits; frequency: ________
□ Y  □ N			ICPs submitting case report form
□ Y  □ N			Isolates being received at state lab
□ Y  □ N			NHSN
□ Y  □ N			Other, please specify: __________

• Updated the text of question 2 to replace “2022” with “2023” 

• This will inform respondents to the year of interest 

• Updated the text of the second method listed from “Retrospective review of received line lists from hospital labs” to “Routinely received line lists from hospital labs”  

• This wording was updated to improve clarity of the question 

No change in burden 

Revision 

Ascertainment of surveillance area and case audits 

3d.  How many laboratories did you audit in 2023? 

• Updated the text of question 3d to replace “2022” with “2023”

Justification:

 

• This will inform respondents to the year of interest 

No change in burden 

Revision 

Ascertainment of surveillance area and case audits 

4.  In 2023, did your site update its inventory of facilities within the EIP catchment area? ___yes  ___no 

• Updated the text of question 3d to replace “2022” with “2023” 

• This will inform respondents to the year of interest 

No change in burden 

Deletion 

Ascertainment of surveillance area and case audits 

7. Does your site have checks in place to recognize decreasing/increasing case counts or rates of MRSA disease?  

  _______ yes _______ no 

           a.  If yes, please describe the check(s) that you use 

 

   b. If yes, how often are the check(s) used?  

           a.If yes, do you plan to use these for MSSA once more surveillance data are available?      ___yes    ___ no 

 

• Deleting question 7b sub-question a (“if yes, do you plan to use these for MSSA once more surveillance data are available”) because we now have several years of surveillance data available and are adding a question about site checks to recognize decreasing/increasing case counts or rates of MSSA disease. 

Decrease 

Addition 

Ascertainment of surveillance area and case audits 

8. Does your site have checks in place to recognize decreasing/increasing case counts or rates of MSSA disease?  

  _______ yes _______ no 

           a.  If yes, please describe the check(s) that you use 

 

b. If yes, how often are the check(s) used?  

 

Justification:

• This new question asks if MSSA data checks for decreasing/increasing case counts or rates of MSSA are used.  If so, we ask for a description of the checks and the frequency with which they are used.   

• This allows us to document site-specific data quality checks.   

0.5-minute increase 

Revision 

Geocoding 

1. Did your site geocode SA cases in 2023? ___yes ___no 

• Updated the text of question 3d to replace “2022” with “2023” 

Justification:

• This will inform respondents to the year of interest 

No change in burden 

Revision 

Vital records linkages 

1. Did your link SA cases to vital records (mortality matching) in 2023?  

___yes ___no 

• Updated the text of question 3d to replace “2022” with “2023”

Justification:

 

• This will inform respondents to the year of interest 

No change in burden 

Deletion 

COVID-19 impact section 

1.   Did COVID-19 response activities affect or delay 2022 iSA surveillance work (e.g., unable to meet iSA deadlines during 2022)?  ___ yes  __ no 

                  a.  If no, how were you able to meet iSA deadlines?   

 b.  If yes, how did COVID-19 response activities delay your iSA work? 

 Justification:

• We have removed all questions in the COVID-19 impact section because the COVID-19 public health emergency declaration expired. 

0.5-minute decrease